DESCRIPTION: State the application's broad, long-termobjectivesand specific aims, makingreferenceto the health relatednessof the project. Describe conciselythe researchdesign and methodsfor achievingthesegoals.Avoidsummariesof pastaccomplishmentsand the useof the first person. Thisabstract is meant to serve as a succinct and accurate description of the proposedwork when separated from the application. If the application is funded, this description, as is, will become public information.Therefore, do not include proprietary/confidentiailnformation. DO NOT EXCEED THE SPACE PROVIDED. Clinical investigators are disappearing from the ranks of federally funded research portfolios to the extent that they have become an "endangered species". To counter this loss, the Training Program in Human Investigation at Thomas Jefferson University prepares investigators for enduring careers pursuing funded hypothesis-driven patient-oriented research and to be role models and mentors to subsequent investigators pursuing similar careers. This Clinical Research Curriculum is composed of a multi-disciplinary faculty with expertise in patient-oriented research, a core of relevant courses and patient- based research experiences, and mentored training in clinical investigation. Successful completion of the program requires >40 course credits and a formal research thesis and defense. Applications are solicited from a large pool (>650) of trainees drawn from different colleges within the university, as well as from clinical training programs at other health care centers in Philadelphia. Eligible applicants include house officers and subspecialty fellows, dentists, pharmacy fellows with a Pharm.D., Ph.D. fellows, and those with a doctoral degree in nursing interested in patient-oriented research. Applicants submit a written application, three letters of recommendation, and transcripts and are selected by an Advisory Committee following personal interviews. Once accepted, trainees pursue a unique program of didactic and applied research components. Formal coursework provides training in essential topics for patient-oriented research including biostatistics, epidemiology, clinical trial design, database management, outcomes research, bioethics and the responsible conduct of research, clinical pharmacology, federal policy and regulations regarding human subjects, scientific writing and grant writing. Coursework is supplemented with components that provide practical experience central to the conduct of patient-oriented research. These include (1) a clerkship in the Jefferson Clinical Research Unit in which trainees participate in a mentored clinical research experience by generating, implementing, completing, and reporting on a randomized clinical trial; and (2) identification of an interest-specific thesis question and advisor, development of a thesis proposal, and conduct of thesis research. Additional novel aspects of this training program include rotations on the Institutional Review Board (IRB) and/or Cancer Clinical Research Review Committee (CCRRC) and a clerkship in the critical review of scientific literature with the editorial staff of the Annals of Internal Medicine. Other important programmatic components include ethics seminars and conferences, journal club in clinical investigation, an in-house research seminar series, and seminars in clinica] investigation with invited speakers from outside the institution. Upon completion of the program, trainees have (1) a thorough understanding of hypothesis formulation and testing in patient-based studies, (2) a theoretical foundation and working knowledge of research designs, (3) insight into the integration of laboratory-based analyses and surrogate endpoints in patient-oriented research, (4) a demonstrated record of achievement conducting randomized clinical trials and other types of studies documented through publication, (5) the ability to critically evaluate the scientific literature, and (6) the ability to employ various computer-based statistical and database packages in research-related. Upon completion of the program, trainees are qualified to perform independent clinical research with certification through a Master's of Science in Human Investigation. PERFORMANCE SITE(S) (organization, city, state) Thomas Jefferson University, Philadlephia, PA Fox Chase Cancer Center, Philadelphia, PA KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below. Start with Principal Investigator. List all other key personnel in alphabetical order, last name first. Name Organization Role on Project Waldman, Scott Thomas Jefferson University Director Greenberg, Howard Thomas Jefferson University Associate Director Leone, Frank Thomas Jefferson University Deputy Director Weinberg, David Fox Chase Cancer Center Associate Director Disclosure Permission Statement. Applicable to SBIR/STTR Only. See instructions.[] Yes [] No PHS 398 (Rev. 05/01) Page 2 Numberpagesconsecutivelayt thebottomthroughout Form Page 2 theapplicationD. onotusesuffixessuchas2a,2b. PrincipInavlestigator/ProgramDirector(Last, First, Middle): Below is a list of Faculty and Advisory Committee who will be they are not listed as key personnel, their Biographical Sketches Name Daskalakis, Constantine Greenberg, Howard (Key Personnel) Hauck, Waiter Laine, Christine Leone, Frank (Key Personnel) Myers, Ronald Nash, David Tolosa, Jorge Waldman, Scott (Key Personnel) Weinberg, David (Key Personnel) Buescher, Georganne Chambers, Christopher Curran, Waker Falkner, Bonita Goldberg, Barry Goldstein, Barry Novielli, Karen Rabinowitz, Howard Waldman, Scott A. contributing to the Clinical Research Curriculum. Although are attached. Role on Project Faculty Faculty Faculty Faculty Faculty Faculty Faculty Faculty Faculty Faculty Advisory Committee Advisory Committee Advisory Committee Advisory Committee Advisory Committee Advisory Committee Advisory Committee Chairman, Advisory Committee PHS 398 (Rev. 05/01) Page 3 Number pages consecutively at the bottom throughout Form Page 2 the application. Do not use suffixes such as 2a, 2b. PrincipInavl estigator/PrDoigreracmt(oLrasFt,irsMt, iddle): Waldman, Scott A. The name of the principal investigator/program director must be provided at the top of each printed page and each continuation page. RESEARCH GRANT